Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
LAROTRECTINIB | A220639 | ALEMBIC PHARMACEUTICALS LIMITED
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Array BioPharma Inc. et al v. Alembic Pharmaceuticals Limited et al 5 patentsANDA 220639larotrectinib sulfate | D. Del. | 2025-08-13 | Active | — |
Bow River LLC v. Alembic Pharmaceuticals Limited et al 2 patentsANDA 220639larotrectinib | D. Del. | 2025-08-13 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.